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Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk

Primary Purpose

Coaching, Cardiovascular Diseases, Metabolic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Health coaching
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coaching focused on measuring Health coaching, Health promoting behaviour, Cardiometabolic disease, Middle-aged

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 40-64 years;
  • have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher;
  • can communicate in Cantonese;
  • able to give informed consent.

Exclusion Criteria:

  • previous diagnosis of transient ischemic attack, stroke, myocardial infarction, atrial fibrillation, coronary heart disease, heart failure, dementia and chronic renal failure;
  • currently on medication to control hyperlipidemia, diabetes or hypertension;
  • with eye or retinal disease;
  • diagnosis of terminal disease with an expected life expectancy less than 12 months;
  • currently participating in any other clinical trial;
  • currently participating in any other structured lifestyle-based or exercise-based programme.

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health coaching

Usual care

Arm Description

Health coaching

Usual care

Outcomes

Primary Outcome Measures

Change in health promoting behaviours
The Chinese version of Health Promoting Lifestyle Profile II (HPLP II) , including health responsibility (9 items), nutrition (9 items), physical activity (8 items) and stress management (8 items), measure the practice of health-promoting behaviours

Secondary Outcome Measures

Change in cardiometabolic risk
Non-laboratory INTERHEART Risk Score (IHRS) assess the risk of cardiometabolic disease
Change in stroke risk
Automatic retinal image analysis (ARIA)-stroke will be used to quantify stroke risk
Change in self-efficacy of adopting health promoting behaviours
Adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used to rate the participants level of confidence in various behaviours
Change in psychological distress
The Chinese version of the shorter version of Depression Anxiety Stress Scales (DASS) developed by Lovibond and Lovibond in 1995 will be used
Change in sleep quality
The Chinese version of the Pittsburg Sleep Quality Index developed by Buysse and team in 1988 will be used
Change in physical activities
International Physical Activity Questionnaire - Chinese (IPAQ-C), a short version, 9-item scale, will be used to assess the level of physical activities
Change in systolic blood pressure
Blood pressure measurement using an electronic sphygmomanometer
Change in diastolic blood pressure
Blood pressure measurement using an electronic sphygmomanometer
Change in Body Mass Index
Body Mass Index will be calculated by the measured height and weight
Change in waist-hip-ratio
Waist-hip-ration will be calculated by the measured waist and hip circumference
Change in blood glucose
Point of care testing of blood for glucose
Change in blood total cholesterol
Point of care testing of blood for total cholesterol
Change in blood urate
Point of care testing of blood for urate

Full Information

First Posted
February 27, 2022
Last Updated
March 8, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05284162
Brief Title
Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk
Official Title
Effects of a Theory-guided Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cardiometabolic disease has been an increasing trend globally and remains the major cause of morbidity and mortality in Hong Kong. Health coaching intervention are generally effective for managing chronic disease and prevention of complication. However, there is fewer attention on the effects of health coaching in primary disease prevention. This study aims to evaluate the effects of health coaching programme on increasing health promoting behaviours in middle-aged adults with cardiometabolic risk.
Detailed Description
Cardiometabolic disease, including metabolic syndrome, prediabetes, type 2 diabetes mellitus, coronary heart disease, myocardial infarction and stroke, has been an increasing trend globally, and increased more than double over 5 years in China [1]. Cardiometabolic disease remains the major cause of morbidity and mortality in Hong Kong [2]. Type 2 diabetes mellitus is associated with increased risk for morbidity and mortality [3]. Ischaemic heart disease and stroke were the major cause of disability-adjusted life years (DALYs) worldwide, resulting in dependence, disability and cognitive impairment [4]. Moreover, midlife stroke risk is associated with cognitive decline within 10 years [5]. A local population health survey has reported that 41.1% of persons between the ages of 45 and 64 are at medium-to-high risk of developing cardiovascular diseases over the next 10 years [6]. Most of the cardiometabolic diseases are attributable to health behaviours. An international study identified risk factors for coronary heart disease and validated the non-laboratory INTERHEART Risk Score (IHRS), which is mainly calculated based on behavioural risk factors, including smoking, stress and physical activity [7]. Also, another study among 32 countries in Asia, Africa, Australia, Europe, the Middle East and USA reported that over 90% of the population attributable risks of stroke could be explained by behavioural risk factors measured by IHRS [8]. Proactive measures to moderate these modifiable risk factors are crucial to halt the increasing trend of cardiometabolic disease. Health coaching interventions are generally effective for managing chronic diseases, including cancer, heart disease, diabetes and hypertension [9]. A systematic review reported health coaching significantly increased physical activity, improved physical and mental health status in patients with chronic disease [10]. Health coaching interventions assist patients to participate actively in their health care, and health coaches collaborate with patients by giving support and promoting self-efficacy in disease management [11]. Despite the widespread use of evidence based health coaching in chronic disease management and prevention of complication, there is fewer attention on the effects of health coaching in primary disease prevention. Therefore, a large-scale, robust clinical trial examining the effects of health coaching in reducing the cardiometabolic risk in middle-aged adults is warranted. The purpose of this study is to address the research gap by evaluating the effects of health coaching programme on increasing health promoting behaviours in middle-aged adults with cardiometabolic risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coaching, Cardiovascular Diseases, Metabolic Diseases
Keywords
Health coaching, Health promoting behaviour, Cardiometabolic disease, Middle-aged

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health coaching
Arm Type
Experimental
Arm Description
Health coaching
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
The health coaching program includes four monthly health coaching sessions for three months.
Primary Outcome Measure Information:
Title
Change in health promoting behaviours
Description
The Chinese version of Health Promoting Lifestyle Profile II (HPLP II) , including health responsibility (9 items), nutrition (9 items), physical activity (8 items) and stress management (8 items), measure the practice of health-promoting behaviours
Time Frame
Change from baseline at 3 months and 6 months post allocation
Secondary Outcome Measure Information:
Title
Change in cardiometabolic risk
Description
Non-laboratory INTERHEART Risk Score (IHRS) assess the risk of cardiometabolic disease
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in stroke risk
Description
Automatic retinal image analysis (ARIA)-stroke will be used to quantify stroke risk
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in self-efficacy of adopting health promoting behaviours
Description
Adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used to rate the participants level of confidence in various behaviours
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in psychological distress
Description
The Chinese version of the shorter version of Depression Anxiety Stress Scales (DASS) developed by Lovibond and Lovibond in 1995 will be used
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in sleep quality
Description
The Chinese version of the Pittsburg Sleep Quality Index developed by Buysse and team in 1988 will be used
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in physical activities
Description
International Physical Activity Questionnaire - Chinese (IPAQ-C), a short version, 9-item scale, will be used to assess the level of physical activities
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in systolic blood pressure
Description
Blood pressure measurement using an electronic sphygmomanometer
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in diastolic blood pressure
Description
Blood pressure measurement using an electronic sphygmomanometer
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in Body Mass Index
Description
Body Mass Index will be calculated by the measured height and weight
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in waist-hip-ratio
Description
Waist-hip-ration will be calculated by the measured waist and hip circumference
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in blood glucose
Description
Point of care testing of blood for glucose
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in blood total cholesterol
Description
Point of care testing of blood for total cholesterol
Time Frame
Change from baseline at 3 months and 6 months post allocation
Title
Change in blood urate
Description
Point of care testing of blood for urate
Time Frame
Change from baseline at 3 months and 6 months post allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 40-64 years; have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher; can communicate in Cantonese; able to give informed consent. Exclusion Criteria: previous diagnosis of transient ischemic attack, stroke, myocardial infarction, atrial fibrillation, coronary heart disease, heart failure, dementia and chronic renal failure; currently on medication to control hyperlipidemia, diabetes or hypertension; with eye or retinal disease; diagnosis of terminal disease with an expected life expectancy less than 12 months; currently participating in any other clinical trial; currently participating in any other structured lifestyle-based or exercise-based programme.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Kwok
Phone
3943 9928
Email
zoekwok@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe Kwok
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Kwok

12. IPD Sharing Statement

Plan to Share IPD
No
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Health Coaching Programme on Health Promoting Behaviours in Middle-Aged Adults With Cardiometabolic Risk

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